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Prepackable dried biological heart valve and its preparation method

A heart valve and drying technology, which is used in the field of medical materials and medical devices, can solve the problems of insufficient assembly toughness and cannot be pre-loaded, and achieve the effect of good toughness and rapid flattening.

Active Publication Date: 2019-01-25
VENUS MEDTECH (HANGZHOU) INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the deficiencies in the prior art above, the purpose of the present invention is to provide a preinstalled dry biological heart valve and its preparation method, aiming at solving the problem that existing interventional biological valves need to be stored in glutaraldehyde solution and cannot be preloaded in In the conveying system, the need for temporary cleaning and pressing assembly and the problem of insufficient toughness

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Fresh porcine pericardium was obtained from a local slaughterhouse. Glutaraldehyde, carbodiimide (EDC), and N-hydroxysuccinimide (NHS) were from Chengdu Best Reagent Company. Water-soluble elastin was from Sigma-Aldrich. Soak the cleaned porcine pericardium in a 5% water-soluble elastin aqueous solution for 24 hours, take it out and wash it, and then use 0.2M carbodiimide (EDC) / 0.1M N-hydroxysuccinimide (NHS ) mixed aqueous solution for cross-linking treatment for 2 hours, and washed with distilled water. Then 0.5% glutaraldehyde aqueous solution (pH 7.4, 25° C.) was used to cross-link for 72 h. Wash with distilled water. Then soak in 50% isopropanol / 50% glycerol for 24 hours and 90% isopropanol / 10% glycerol for 24 hours successively at 25° C. to achieve gradient dehydration of the biological valve. A pre-installed dry biological heart valve with good toughness is prepared.

[0041] After testing, it was found that the dry biological heart valve prepared in this im...

Embodiment 2

[0043] Fresh porcine pericardium was obtained from a local slaughterhouse. Glutaraldehyde, carbodiimide (EDC), and N-hydroxysuccinimide (NHS) were purchased from Chengdu Best Reagent Company. Hyaluronic acid comes from Shanghai Aladdin Biochemical Technology Co., Ltd. Soak the cleaned porcine pericardium in a 5% hyaluronic acid aqueous solution for 24 hours, take it out and rinse, and then use 0.2M carbodiimide (EDC) / 0.1M N-hydroxysuccinimide (NHS) The mixed aqueous solution was cross-linked for 2 hours, and washed with distilled water. Then 0.5% glutaraldehyde aqueous solution (pH 7.4, 25° C.) was used to cross-link for 72 h. Wash with distilled water. Then soak in 50% isopropanol / 50% glycerol for 24 hours and 90% isopropanol / 10% glycerol for 24 hours successively at 25° C. to achieve gradient dehydration of the biological valve. A pre-installed dry biological heart valve with good toughness is prepared.

[0044] After testing, it was found that the dry biological heart ...

Embodiment 3

[0046] Fresh porcine pericardium was obtained from a local slaughterhouse. Glutaraldehyde, carbodiimide (EDC), and N-hydroxysuccinimide (NHS) were purchased from Chengdu Best Reagent Company. Water-soluble elastin was from Sigma-Aldrich. Hyaluronic acid comes from Shanghai Aladdin Biochemical Technology Co., Ltd. Soak the cleaned porcine pericardium in a mixed aqueous solution of 2.5% water-soluble elastin and 2.5% hyaluronic acid for 24 hours, take it out and wash it, and then use 0.2M carbodiimide (EDC) / 0.1M N- Hydroxysuccinimide (NHS) mixed aqueous solution was cross-linked for 2 hours, and washed with distilled water. Then 0.5% glutaraldehyde aqueous solution (pH 7.4, 25° C.) was used to cross-link for 72 h. Wash with distilled water. Then soak in 50% isopropanol / 50% glycerol for 24 hours and 90% isopropanol / 10% glycerol for 24 hours successively at 25° C. to achieve gradient dehydration of the biological valve. A pre-installed dry biological heart valve with good tou...

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Abstract

The invention discloses a prepackable dry biological heart valve and its preparation method. The preparation method comprises: the step A, soaking fresh animal pericardium in an aqueous solution of soluble elastin or glycosaminoglycans, performing primary crosslinking reaction in carbodiimide / N-aminoglycosaminogly mixed solution, and bonding the elastin or glycosaminoglycans to the pericardium bychemical bonds; and the step B, the pericardium after primary crosslinking is subjected to secondary crosslinking reaction by using glutaraldehyde aqueous solution, and then the pericardium after secondary crosslinking is dried to obtain a prepackable dry biological heart valve. The dried biological heart valve prepared by the preparation method of the invention has good toughness and can be quickly flattened under the simulated bend pressure test.

Description

technical field [0001] The invention relates to the field of medical materials and medical devices, in particular to a pre-installed dry biological heart valve and a preparation method thereof. Background technique [0002] Heart valve disease is a common disease of valve degeneration. Anatomically, it manifests as narrowing of the blood passage or valvular insufficiency. Treatment of heart valve disease includes open heart valve replacement surgery and percutaneous heart valve replacement surgery. Thoracotomy is traumatic, high-risk, slow recovery, and requires extracorporeal circulation support, which is unacceptable to many patients. Percutaneous heart valve replacement surgery has become the main trend of valve surgery in the future because of its small trauma and low risk to patients. Biological heart valves refer to a class of biomedical materials used to replace human diseased heart valves. Biological heart valves are generally prepared by cross-linking glutaralde...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/36
CPCA61L27/3625A61L27/3641A61L27/3687A61L2400/18A61L2430/20
Inventor 王云兵雷洋李高参杨立林浩昇邝大军余金城
Owner VENUS MEDTECH (HANGZHOU) INC
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